Consumer Reports Says Most Patients Ought To “Take A Pass” — On Merck’s New Insomnia Offering

Overnight, the quite well-respected Consumer Reports franchise issued a rather downbeat assessment of Merck’s suvorexant, branded as Belsomra® in the US. To be fair, one of the independent pharmaceutical experts the magazine relied upon was a detractor who sat on the FDA Advisory panel that reviewed the candidate in 2013. However, both expert reviewers pointed to data that suggested only a scant sleep-time advantage over a placebo — coupled to a more than occasional groggy morning-after effect. So the underwhelming review is based on pretty solid independent science, in my experienced view.

More specifically, at higher doses (beyond the current FDA-approved label’s indication) Merck had (back in 2013) shown improved sleep times, to the FDA panel, during review — but the Advisory panel was very concerned about the morning after fogginess reported by some — at those higher doses. Net, net: I think Belsomra will sell only modestly for Kenilworth. I think prescribers will worry about the dangers of driving the morning after, in the wider populations of mild sleep disorder patients — and so the drug’s US market penetration will be limited.

. . . .[Consumer Reports] commissioned two drug safety experts — Steven Woloshin, M.D., and Lisa M. Schwartz, M.D., both at the Geisel School of Medicine at Dartmouth — to review the research and prepare a Drug Facts Box for Belsomra. Schwartz served on an FDA advisory committee of experts that looked at Belsomra in 2013.

Their analysis shows that people who took a 15 mg or 20 mg dose of Belsomra every night for 3 months fell asleep just 6 minutes faster on average than those who got a placebo pill. And the Belsomra group slept only 16 minutes longer — 6 hours and 12 minutes total vs. 5 hours and 56 minutes for the placebo group.

Those small improvements in sleep didn’t translate to people feeling more refreshed. Instead, more people who took Belsomra felt drowsy the next day compared with those who took a placebo. . . .